BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD CONNECTA¿ STOPCOCK

    MDR report key: 8016352 · Received October 29, 2018

    Report

    Report Number
    9610847-2018-00352
    Event Type
    Malfunction
    Date Received
    October 29, 2018
    Date of Event
    October 9, 2018
    Report Date
    December 3, 2018
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    FMG
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBERS 8037509 & 8100700. BD ENGINEERS HAVE NOTED A TREND IN LEAKAGE FOR 8037509, BUT THIS IS THE ONLY RECORDED INSTANCE OCCURRING IN LOT 8100700. ACCORDING TO THE SAMPLING PLAN APPLIED FOR PRODUCT PERFORMANCE, THESE LOTS WERE ACCEPTED AND RELEASED, WITH NO DEFECTS BEING NOTED DURING FINAL ASSEMBLY OR VISUAL INSPECTIONS. OUR QUALITY ENGINEERS SUBJECTED THE DEVICES SUBMITTED TO LEAKAGE TESTING. THE RESULTS THESE TEST WERE ABLE IDENTIFY LEAKAGE BETWEEN THE HOUSING AND TAP JUNCTION. THIS TYPE OF NONCONFORMANCE IS CAUSED BY WORN COMPONENTS IN THE MANUFACTURING MACHINERY. WHEN WORN DOWN, THESE COMPONENTS CAN LEAD TO AN IMPROPER CONNECTION BETWEEN THE VALVE HOUSING AND THE TUBING OF THE DEVICE, CAUSING A LEAK TO OCCUR AT THIS JUNCTION. TO PREVENT THE REOCCURRENCE OF THIS EVENT, THE WORN COMPONENT WAS REPLACED ON (B)(6) 2018. BD WILL CONTINUE TO TRACK AND TREND FOR THIS ISSUED FOR THIS ISSUE. NOGALES WILL OPEN A CAPA (#629955) NOT BECAUSE OF THE CID AS IT IS ¿NO CAPA REQUIRED¿ AS PER CPR-028 BASED ON THE SEVERITY AND OCCURRENCE CALCULATION, THE REASON TO OPEN THE CAPA IS TO BETTER SUPPORT THE EXPOSURE TO EXTERNAL STAKEHOLDERS, THE FOCUS OF THE CAPA WILL BE BATCH 8037509 AND SUB-ASSEMBLY LOTS RELATED TO THAT BATCH.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE OF THE BD CONNECTA¿ STOPCOCK THE 3-WAY STOPCOCK LEAKED FROM INJECTION PORT. THERE WAS NO REPORT OF EXPOSURE, INJURY, OR MEDICAL INTERVENTION.

    Additional Manufacturer Narrative · 1

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 8037509, MEDICAL DEVICE EXPIRATION DATE: 2021-01-31, DEVICE MANUFACTURE DATE: 2018-03-28 . MEDICAL DEVICE LOT #: 8100700, MEDICAL DEVICE EXPIRATION DATE: 2021-03-31, DEVICE MANUFACTURE DATE: 2018-05-24. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING USE OF THE BD CONNECTA¿ STOPCOCK THE 3-WAY STOPCOCK LEAKED FROM INJECTION PORT. THERE WAS NO REPORT OF EXPOSURE, INJURY, OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    857822 BD CONNECTA¿ STOPCOCK STOPCOCK FMG BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 Other